Protocol for a randomized controlled trial of a psychoeducation material to reduce psychological distress levels in women with breast cancer post mastectomy in Indonesia

doi:10.21203/rs.3.rs-3245098/v1

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Study protocol

Protocol for a randomized controlled trial of a psychoeducation material to reduce psychological distress levels in women with breast cancer post mastectomy in Indonesia

https://doi.org/10.21203/rs.3.rs-3245098/v1

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Background

The prevalence of post-mastectomy patients who experience symptoms of anxiety and depression are 40%, the impact of psychological stress due to mastectomy includes loss of self-confidence, specifically, body image, by 63%, lifestyle changes by 51.8%, feeling useless as much as 58% and feel less cared for by 75%. Patients who experience post-mastectomy stress may experience psychological side effects, including a 24% increased chance of cancer recurrence, a 30% increased risk of all-cause mortality, and a 29% greater risk of developing a particular type of breast cancer. The current study will examine whether our recently created nurse-guided psychoeducational material for Indonesian breast cancer survivors who have had mastectomy reduces psychological discomfort.

Methods

In Indonesia's Kariadi Hospital Semarang Centre Java, 84 patients will participate in a randomised controlled experiment. Data will be gathered at the start of the intervention (pre-assessment), 3 to 5 days later (post-assessment − 1), and 1 to 2 weeks later (follow-up assessment). The primary outcome is level of psychological distress and serotonin levels. Secondary outcomes are breast cancer post mastectomy score pain level, body image and fatigue.

Discussion

If effective, psychoeducation nurse-guided materials will be tested and put into practise in a variety of contexts for city local cares that offer health education/psychoeducation to women with breast cancer following mastectomy (such as in the hospital in West Java, Indonesia).

Trial registration

TCTR20230501003. Date: Mei 1th,2023.

Breast cancer post mastectomy

Material

Psychoeducation

Psychological distress

Indonesia

Cancer is the leading cause of death globally. The World Health Organization (WHO) released data that about 10 million deaths were cancer cases (1). In Indonesia, previous breast cancer studies explained that about 67% of women with breast cancer symptoms who came to the hospital stopped a full examination (2), and more than 80% of Indonesian women, have just started treatment with conditions already at an advanced stage (3). The condition becomes more severe because it must be treated and treated. The most common advanced stage of treatment is surgery, with predictions of cancer surgery increasing from 9,065,000 in 2018 to 13,821,000 in 2040 (4). This increase has attracted the attention of nurses to provide care for women with breast cancer in various conditions, especially after surgery.

The first treatment for women with breast cancer, at treatment intervals, is mastectomy. This procedure is performed before chemotherapy and radiotherapy (5, 6). The study of Lovelace and colleagues, explains that the prevalence of breast cancer patients undergoing surgery is about 90%, with unilateral or bilateral mastectomy without reconstruction(7). This action will permanently change a woman's appearance(8), because the loss of breasts is a loss of female identity, a symbol of femininity, sex, beauty, a mother, and the function of breastfeeding a baby(9).

Women's breast cancer mastectomy is a traumatic event that has an impact on psychological aspects(10). Impaired self-concept manifests as altered body image, loss of self-identity, shifts in social roles, changes in self-ideal, and declines in self-esteem(7, 11, 12). Several psychological problems and mental disorders such as anxiety, depressive symptoms, and low self-esteem occur in breast cancer women with mastectomy(13, 14). Williams and colleagues' research reveals increased levels of anxiety and depression in breast cancer women after surgery(15). The Civilotti and colleagues study also reported that 40% of mastectomy patients experienced clinically relevant anxiety symptoms and about a quarter of patients experienced significant depressive symptoms(16). The study of Simunovic and colleagues reported that the stressor level among radical mastectomy patients was 19% higher than that of partial mastectomies(17). Several studies have also reported that the symptoms of stress and withdrawal in post-mastectomy patients are similar to the characteristics of post-traumatic stress disorder (PTSD)(18, 19). Calderon and colleagues' research revealed that the prevalence of psychological and physical symptoms in mastectomy women was 23.3% of symptoms of pessimism, 40.0% of symptoms of depression, 8.8% of fatigue, and 4.2% of pain(20). This shows that the psychological problems of breast cancer women with mastectomy need to be given the right intervention so that it does not have a wide impact.

The impact and risk of mastectomy results in cancer recurrence by 24%, an increase in causes of death by 30%, and an increase in the specific risk of breast cancer by 29% (21). Based on mastectomy patients' psychological, neuro, and immunological risks, an adequate psychosocial intervention is needed. Adequate psychosocial intervention becomes very important to reduce anxiety, stress, and depression in post-mastectomy patients. Various psychoeducational interventions to reduce post-mastectomy anxiety and depression have been carried out, but the results vary(22, 23). Likewise, many developing countries' psychoeducational interventions are still ineffective in reducing post-mastectomy anxiety and depression(23).

Due to its advantages in addressing the psychosocial needs of breast cancer patients through social support, psychoeducation, psychotherapy, pharmacotherapy, and other complementary interventions, psychoeducation is crucial as a psychosocial intervention given by professionals like nurses, psychologists, and oncologists(24). According to several research, psychoeducation is a better intervention since it helps patients and their families understand the sickness and how to treat it, which improves the patient's coping mechanisms. A meta-analysis by Matsuda and colleagues from 2014 demonstrated that psychoeducational therapies have a beneficial impact on enhancing the emotional wellbeing of breast cancer patients(25). In 2020, Guarino and colleagues' research also reported in a meta-analysis reporting that psychoeducational interventions are psychosocial interventions to help reduce symptoms of anxiety and depression(26). In 2021, Younis and colleagues' research revealed that psychoeducational interventions were effective in improving adaptive coping strategies(27).

Psychoeducation has several advantages over other psychosocial interventions. According to Lukens, psychoeducation is a flexible intervention, many studies have been proven as evidence base practice, various intervention formats such as individual, group and with mentors, interventions that empower patients, and a more collaborative role of facilitator(28, 29). The choice of psychoeducation as an intervention that cures psychological problems, is because the intervention involves other disciplines or interprofessional, namely oncologists, nurses, and psychologists(30).

The development of psychoeducation in women with breast cancer in Indonesia is still small. The development of existing psychoeducation is new in the female population with breast cancer symptoms or diagnostic intervals. Setyowibowo and colleagues' research in women with symptoms of breast cancer reveals that psychoeducation can reduce the time to a definitive diagnosis(31). So from the results of these studies, it is necessary to continue research at intervals of treatment and care. Based on this, researchers are interested in researching the development of psychoeducation for treatment intervals entitled the development of psychoeducation to reduce stress levels in post-mastectomy breast cancer women.

The purpose of this study is to assess the efficacy of psychoeducational nurse-led interventions in lowering psychological distress levels in post-mastectomy breast cancer patients who were not hospitalised. We also looked at how it affected fatigue, body image, and pain intensity as a secondary goal. Finally, we looked at how measuring serotonin levels affected the results.

Design

Hospitals will be used as the randomisation unit in this project, which will be a randomised controlled trial. We will conduct the study at Kariadi Hospitals in Semarang, Indonesia, which have consented to take part. Due to the fact that there are only one hospital, we will utilise a pre- and post-control design. Psychoeducation nurse-guided materials or control (treatment as usual/TAU) will be administered at intervals. In the trial, post-mastectomy breast cancer patients will be compared to TAU and psychoeducation nurse-guided material. The experimental group in this trial received TAU alone while receiving nurse-guided psychoeducation as part of the intervention, while the control group did not get either of these treatments. Serotonin levels and psychological anguish are the main outcomes. Body image, weariness, and pain level are ancillary effects.

Participants

42 participants in the Treatment-as-Usual (TAU) control group and 42 individuals in the experiment/intervention group will make up the 84 patients in the experiment study with the randomised pre-post with control study. Participants will be chosen from Kariadi Hospital in Semarang, Centre Java, Indonesia, which is a good representation of the medical centres in Semarang. Participants will be brand-new (outpatient) patients who underwent a mastectomy and were treated for breast cancer in a hospital room. When reporting to the treated room in the hospital, patients who are eligible for the intervention programme will be requested to participate in the study. Women with post-mastectomy, breast cancer stages I to III, ages 18 to 49, a sufficient command of the Indonesian language, a low to high anxiety level, and the following exclusion criteria will be used: have received psychoeducation before, history of antidepressant therapy: selective serotonin reuptake inhibitors (SSRIs), patients who have been on chemotherapy and radiotherapy programs and cognitive, psychiatric or other serious malignancy.

Procedure

The eligible volunteers will be informed about the study by the medical professionals (oncologist or nurse) (see Fig. 1). “Patients will be contacted by the research assistant so that they can be informed about the study and give their verbal and written consent. Patients who agree to participate will be asked to fill out the following questionnaires: a sociodemographic questionnaire, a medical history questionnaire, an enzyme-linked immunosorbent assay (ELISA) test to measure serotonin levels, a numeric rating scale (NRS) for pain intensity, a body image scale (BIS), a fatigue subscale from the Functional Assessment of Chronic Illness Therapy (FACIT), and the Functional Assessment of Chronic Illness Therapy. In accordance with WHO recommendations(32), illiterate participants will provide oral consent and a thumbprint in place of a signature.” The control group will continue receiving standard care (TAU), while the intervention group will be given the nurse-led psychoeducation package. Within 3–5 days, participants must read and watch the intervention package, or submit an alternative plan. The post-intervention evaluation will happen three to five days after the intervention, or whenever the plan is given back. Participants will receive the following questionnaires to complete: “The Body Image Scale (BIS) rates body image, the Hospital Anxiety-Depression Scale (HADS) Questionnaire rates psychological distress on a scale of 1 to 10, Both pain and fatigue can be measured on a 1 to 10 scale using the Numeric Rating Scale (NRS) and the Functional Assessment of Chronic Illness Therapy-fatigue subscale (FACIT-F),respectively.” After an initial post-intervention examination, another assessment will be scheduled one to two weeks later. These include the Numeric Rating Scale (NRS), the Body Image Scale (BIS),”the Functional Assessment of Chronic Illness Therapy-fatigue subscale (FACIT-F), and the Hospital Anxiety and Depression Scale (HADS) Questionnaire, which evaluates pain. which measures fatigue, and the ELISA test, which measures serotonin level, will all be required of the participant.” To lessen the degree of psychological anguish, the researcher will examine the patient's medical file. The stage, history of treatment, and frequency of mastectomy surgery will all be examined by the researchers when they go over the patient's medical data. This time frame was picked since it also meets a requirement. background as a trained research assistant An evaluation will be done by the nurse. The perception equations will be taught to all research assistants over the course of three days, covering topics such as how to supply instruments, details on psychoeducational needs, delivery methods, and how to explain psychoeducational materials in multimedia medium. Regular supervision by the principal investigators and the principal researcher will be used to carry out continuous monitoring.

Intervention

A nurse-led resource bundle called Psychoeducation includes video content. The goal of the audiovisual education and psychotherapy provided by different healthcare professionals (oncologists, psychologists, and nurses) is to lessen patients' psychological anguish and raise serotonin levels. The conceptual structure (blueprint) of the psychoeducation nurse led package video material was developed based on five focused group discussion sessions with healthcare professionals (2 oncologists and 10 nurses). A group of experts in healthcare communication, oncology, health psychology, and a breast cancer post-mastectomy survivor assessed the conceptual framework (blueprint) after that. The intervention plan as well as the usability and acceptability of the created interventions were subject to suggestions and comments from the study team. The panel additionally suggested that a group of audiovisual experts create the video content. “The psychoeducation nurse-guided models include the following information: 1) a brief explanation of breast cancer post mastectomy in order for the patients to have an accurate understanding and stimulation to seek information from reliable sources (oncologist)”; 2) distress management, koping skill and spirituality in patient (psychologist); 3) self care: caring in pain management, nutrition management (nurses) ; and 4) recommendation to seek support from significant persons and institutions. The audiovisual component of the nurse-guided psychoeducation package is a 15-minute video with healthcare practitioners and a 30-second video of a breast cancer survivor who underwent a mastectomy and discussed their experiences while advocating social support and active coping. The psychoeducation audiovisual integrative model prototype was tested with post-mastectomy survivors, oncologists, and 15 patients. This pilot study's findings demonstrated that the prototype was workable and practical. The nurse directed psychoeducation package video materials will be distributed to the experimental groups by trained research assistants. They will briefly explain to the patient the purpose of the audiovisual nurse guided psychoeducation package and how to use it.

Treatment as usual (TAU)

TAU in a Kariadi Hospital often entails treatment standards, a clinical pathway, and physician examination protocols. There isn't much information available about breast cancer post-mastectomy health, and what there is typically consists of oral education only. The Kariadi Hospitals involved in the study do not offer psychosocial assistance for patients with breast cancer post-mastectomy complaints to help the patient during the evaluation process.

Instruments

Primary outcome

The main indicator of success will be psychological suffering. Pre- and post-assessments are used to measure this. This will be evaluated using the Hospital Anxiety and Depression Scale (HADS) Questionnaire, subjective reports of distress, and the ELISA test for measuring serotonin levels. “Hospital Anxiety and Depression Scale (HADS) will be used to assess anxiety and depression symptoms. The HADS is a 14-item self-report survey used to evaluate the level of emotional suffering among patients.”The HADS-A measures anxiety, and the HADS-D measures depression; both are included. There are seven elements in each subscale. The Cronbach's coefficient (alpha) values for the Indonesian version of the HADS were 0.77 and 0.74, respectively, indicating appropriate psychometric qualities (33). Serotonin normal values: 101–283 nanograms per milliliter (ng/mL). Indicator when serotonin levels decrease (< 101 ng/mL): the patient is experiencing psychological distress.

Secondary outcome

Patients' demographic information (such as age, education, ethnicity, employment, marital status, religion, income, insurance status, and mental health status) will be collected using a standard sociodemographic and medical history form (SDMH). family/social support, and surgical procedure. Information about the kind, stage, and method of cancer therapy can also be found by looking through the patients' medical records.

The patient's degree of pain will be evaluated using the Numeric Rating Scale (NRS), the Body Image Scale (BIS), and the Functional Assessment of Chronic Illness Therapy-fatigue subscale (FACIT-F). We will also utilise the BIS test, which consists of 10 items and has four possible outcomes: no, occasionally, frequently, or very frequently. Results of the scoring system are as follows: 0–10 = normal; 11–20 = mild instances; 21–30 = moderate cases; and 31–40 = severe cases. Cronbach's validity test has a score of 0.900 (34). This tool makes use of the Functional Assessment of Chronic Illness Therapy-Fatigue Subscale (FACIT-F). How to measure by selecting one of the following options: no, occasionally, frequently, or very frequently. This measurement, which consists of 13 statements, is meant to evaluate fatigue and how it affects daily life. Score outcomes: 0–10 = normal, 11–20 = mild fatigue, 21–30 = moderate fatigue, and 31–40 = severe fatigue (35).

Analysis plan

Descriptive statistics, such as percentages for categorical data and means and standard deviations for continuous data, will be used to summarise demographic characteristics. Graphs will be used to present the tabulated descriptive statistics. The quantitative data analysis with homogeneity analysis performed by carrying out the data normality test using Kolmogorov-Smirnov. For categorical data, a Chi Square proportion difference test was used to examine homogeneity, and for numerical variables, There was a comparison of means using the Mann Whitney non-parametric test. Analysis of pre- and post-treatment data comparing the experimental and control groups on measures of psychological distress, serum serotonin levels, pain, body image soreness, and fatigue. When the data is not normally distributed, the Wilcoxon rank test is employed instead of the paired sample t-test. Quantitative analysis of serum serotonin levels, pain levels, body image scores, levels of fatigue, and difference test delta scores for psychological distress. Independent sample t-test for parametric mean difference testing if data follows a normal distribution; Mann-Whitney u test for non-normal data if the t-test fails to detect a significant difference. This different test is to determine the effect of psychoeducation on psychological distress, serum serotonin levels, pain level, body image score and fatigue level. Testing of patient characteristic variables was carried out using a co-variate analysis test on the characteristics of post-mastectomy breast cancer women. This test is to test the characteristics of patients with psychological distress scores and serotonin levels. Testing of patient characteristic variables was carried out using a co-variate analysis test on the characteristics of post-mastectomy breast cancer women. This test is to test the characteristics of patients with psychological distress scores and serotonin levels. Testing of patient characteristic variables was carried out using a co-variate analysis test on the characteristics of post-mastectomy breast cancer women. This test is to test the characteristics of patients with psychological distress scores and serotonin levels.

Ethics

On March 24th, 2023, Document No. 1452/EC/KEPK-RSDK/2023 (Additional file 1), the Health Research Ethics Committee of Dr. Kariadi General Hospital Semarang approved the project locally.

Delivering nurses-guided psycho-education materials, specifically designed to lower psychological distress levels and boost serotonin levels - like our “Psychoeducation nurse-guided package audiovisual material” - may be an efficient way to provide psycho-educational therapies. The purpose of this study is to evaluate the effectiveness of psychoeducational materials developed by nurses in assisting women who have had post-mastectomy therapy for breast cancer in coping emotionally. The “psychoeducation nurse guided package audiovisual material” will be evaluated and implemented in a variety of primary care settings (such as in Hospitals West Java and city another) in an effort to provide health education/psycho-education for women with breast cancer following mastectomy that is likely to lessen psychological distress and increase serotonin levels.

Distress levels are measured using the Hospital Anxiety and Depression Scale (HADS)”questionnaire, pain levels are measured using a numeric rating scale, body image is measured using the Body Image Scale (BIS), fatigue is measured using the Functional Assessment of Chronic Illness Therapy-fatigue subscale (FACIT-F), and serotonin levels are measured using an enzyme-linked immunosorbent assay (ELISA).”According to data collected by the World Health Organisation (WHO), PTSD affects

Competing interests

The authors declare that they have no competing interests.

Consent for publication

Participants listed on the informed consent form will be asked for their written consent before publication.

Ethics approval and consent to participate

On March 24, 2023, the Health Research Ethics Committee of Dr. Kariadi General Hospital Semarang (RSDK), Document No. 1452/EC/KEPK-RSDK/2023, approved the project locally. Participants' informed consent will be sought once they have read and comprehended the objective, advantages, and potential dangers of the research. The form will need to be signed by those who concurred. Although the study does not anticipate any unfavourable outcomes, individuals are always free to decline or end their involvement if they are uncomfortable. The qualified research personnel will assist the participant if she needs assistance or is illiterate in understanding the study and other connected topics.

Author details

¹Medical and Health Science Doctoral Programme, Diponegoro University, Semarang, Indonesia. ²Biomedical Master Science Programme, Diponegoro University, Faculty of Medicine, Semarang, Indonesia.³Faculty of Psychology, Padjadjaran University, Bandung, Indonesia. ⁴Nursing Science Program, Faculty of Medicine, Diponegoro University, Semarang, Indonesia.

Authors’ contributions

AA, DM, YW, and HS wrote the manuscript.”The substance and ethical challenge of the intervention material were discussed by YW, HS, and AA. YW, HS, and AA, together with sample size and power calculations, statistical analysis descriptions, and allocation and randomisation procedures.”All authors have reviewed and approved the final manuscript.

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Competing interest reported. This study protocol manuscript wants to be published o updating data in the Thai Clinical Trial Registry (TCTR)

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Protocol for a randomized controlled trial of a psychoeducation material to reduce psychological distress levels in women with breast cancer post mastectomy in Indonesia

Status:

Version 1

Abstract

Figures

Background

Method

Design

Participants

Procedure

Intervention

Treatment as usual (TAU)

Instruments

Primary outcome

Secondary outcome

Analysis plan

Ethics

Discussion

Abbreviations

Declarations

Competing interests

Author details

Authors’ contributions

References

Additional Declarations

Status:

Version 1